Intas Pharmaceuticals Limited
⚠️ High Risk
FEI: 3014639576 • Gangtok, Sikkim • INDIA
FEI Number
3014639576
Location
Gangtok, Sikkim
Country
INDIAAddress
Bhagey Khola, Sikkim Rangpo East, Gangtok, Sikkim, India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/19/2025 | 61NCA84DESVENLAFAXINE SUCCINATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/19/2025 | 66NDY06ARIPIPRAZOLE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 12/3/2025 | 61MCB51PREGABALIN (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/3/2025 | 61ECB09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/24/2025 | 66NDY04RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | Division of Northeast Imports (DNEI) | |
| 6/26/2025 | 62JDY99ANTI-PARKINSONIAN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/26/2025 | 61NDY69GABAPENTIN (ANTI-DEPRESSANT) | Division of Southeast Imports (DSEI) | |
| 11/7/2022 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/15/2021 | 61NDB76PAROXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/7/2021 | 65PCY99REGULATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/7/2021 | 66WCY99IMMUNOMODULATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/7/2021 | 62TCY99ANTI-SECRETORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/24/2020 | 61TDB31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/20/2020 | 61MDY35DIVALPROEX SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/6/2019 | 61XDA51LEVOCETIRIZINE DIHYDROCHLORIDE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/7/2019 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/29/2017 | 66NDA07OXCARBAZEPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2015 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Intas Pharmaceuticals Limited's FDA import refusal history?
Intas Pharmaceuticals Limited (FEI: 3014639576) has 18 FDA import refusal record(s) in our database, spanning from 7/29/2015 to 12/19/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Intas Pharmaceuticals Limited's FEI number is 3014639576.
What types of violations has Intas Pharmaceuticals Limited received?
Intas Pharmaceuticals Limited has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Intas Pharmaceuticals Limited come from?
All FDA import refusal data for Intas Pharmaceuticals Limited is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.